# K062699: Perfusor Space Infusion Syringe Pump System

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Oct 26, 2006 after 45 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904518 (1990). 14 ancestors in all.
4 later devices descend from it; 4 cite it directly.
4 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022575: Perfusor Compact with FM System, B.Braun Medical, Inc. (2002) Summary page 1.
- K030459: Medley System with Medication Management System (MMS), Alaris Medical Systems, Inc. (2003) Summary page 1.
- K023264: Medley Syringe Pump Module System, Model 8110, Alaris Medical Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K092313: Perfusor Space Infusion Syringe Pump System (2009), 1 descendant of its own
- K191910: SpaceStation MRI (2020), 0 descendants of its own
- K172831: Perfusor® Space Syringe Infusion Pump System (2018), 0 descendants of its own
- K111381: Medi-Sis Syringe Infusion System (2012), 0 descendants of its own

## Indications for use
The Perfusor ® Space Infusion Syringe Pump System includes an external transportable electronic infusion syringe pump and pump accessories. The system is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Perfuisor® Space Infusion Syringe Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances).

Source page: https://510kreport.com/device/K062699
Methodology: https://510kreport.com/methodology